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Recruiting NCT07701733

A Study of Lung Cancer Risk

Observational Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 40 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

ARISE: Assessing Lung Cancer Risk in Never-Smoking Women

Overview

The researchers are doing this study to learn more about factors that may increase the risk of lung cancer in people who have never smoked. This information may help predict which people who have never smoked may be more likely to get lung cancer.

Interventions

  • Other Questionnaire
    The study questionnaire will be administered at a regular treatment visit for case patients and at a study-specific visit for control participants. At the same visit, 1 vial of blood will be collected for genomic analysis for research purposes from both case patients and control participants. Collection of demographic information and exposure data.

Primary outcome measures

  • Identify factors associated with the risk of NSCLC [Time frame: 3 years]

Eligibility criteria

Criteria:

  • Female at birth
  • Age 40-74 years
  • No smoking history
  • Participants must be never-smokers, defined as having smoked <100 cigarettes in their lifetime
  • Documentation of disease - case patients

o Case patients must have pathologically confirmed primary lung adenocarcinoma. New and prevalent cases will be eligible. Case patients with a history of prior non-lung cancer will be eligible for the study unless actively being diagnosed or treated for another form of cancer at the time of enrollment.

  • Criteria for control participants
  • Control participants must have no personal history of lung cancer, symptoms suspicious for lung cancer, or suspicious pulmonary nodules. Participants recruited as controls and found on imaging to have lesions suspicious for lung cancer will be excluded from analysis and followed prospectively. Data regarding these participants will be reported in a sensitivity analysis. Additional control participants will be recruited to ensure balanced age- and race-matched enrollment by frequency matching. Control participants with a history of prior non-lung cancer will be eligible for the study unless actively being diagnosed or treated for another form of cancer at the time of enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale

Identifiers

NCT: NCT07701733 · 26-239

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗